On September 30, 2019, FDA announced the availability of a draft guidance for Industry, titled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.” This guidance addresses a special pathway for approval of animal drugs that address serious or life-threatening diseases or conditions, or …
On Dec. 18, 2018, the Center of Veterinary Medicine (CVM) of FDA announced the publication of its 2017 Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. This report is required by the Animal Drug User Fee Amendments of 2008. Under that law, …
To the possible chagrin of those who think that FDA lacks jurisdiction over gene-editing of plants and animals, the Agency announced a Plant and Animal Biotechnology Innovation Action Plan that lays out actions the Agency is taking to help harness the potential benefits of the …
On Sept. 10, 2018, the Food Safety Inspection Service (FSIS) of the USDA and FDA announced a joint public hearing scheduled for Oct. 23-24, 2018. The federal register announcement, explains that this will follow a meeting by FDA’s Science Advisory Board on October 22, 2018. The …
On August 17, FDA announced that the Animal Drug and Animal Generic Drug User Fee Amendments of 2018 had been signed into law. As the name of the law suggests, it reauthorizes the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User …
On Monday, January 21 (amid the government shutdown) the Center for Veterinary Medicine of the Food and Drug Administration (CVM) released a draft guidance document addressing Subpart C of the Agency’s regulation titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food …
In likely the first time since the United States Court of Appeals for the Fifth Circuit decided Medical Center Pharmacy v. Mukasey, 536 F.3d 385 (5th Cir. 2008) (see our previous post here), a federal court located in the Western District of Louisiana (within the …
Cue up “For The Love of Money” by The O’Jays (and theme song of The Apprentice) . . . The Trump Administration’s Fiscal Year 2018 Budget Proposal is out! On May 23, 2017, The White House Office of Management and Budget released President Trump’s Fiscal Year …
It has been 40 years since Steve Perry changed the lyrics to the iconic song Lights to refer to San Francisco rather than Los Angeles. As it turns out, litigants looking to gain easy access to otherwise confidential agency documents may want to make the …
As we reported previously, just before President Trump took the oath of office, FDA issued two guidance documents regarding its approach to the regulation of genetically engineered (“GE”) animals. One of those guidance documents was a revision of a 2009 guidance document that, for the first …
Just before President Trump took office, FDA issued a series of documents detailing how it would regulate the products of gene editing. Specifically, FDA issued policy statements in the form of an announcement on its website and an article in the FDA Voice, FDA’s official …
The American Conference Institute (“ACI”) will hold the Second Annual Legal, Regulatory and Compliance Forum on Animal Health: Veterinary Drugs, Therapeutics, and Animal Food on September 13-15, 2016, in New York City at The Carlton Hotel. This forum will help attendees make sense of the legal …
By Riëtte van Laack & Wes Siegner – Under the FDC Act, dog and cat food products that are intended to treat or prevent disease and to provide nutrients in support of the animal’s daily nutrient needs can be regulated as drugs or foods or both. …
By Jay W. Cormier & Diane B. McColl – This past Tuesday, FDA issued a Notice of Opportunity for Hearing (NOOH) proposing to withdraw approval of all new animal drug applications for carbodox that have an indication for use in medicated swine feed. Specifically, FDA is …
By Jay W. Cormier – On December 8, 2015, FDA issued a complex set of approvals for a unique product, Kanuma (sebelipase alfa). Kanuma is indicated for the treatment of a rare disease known as lysosomal acid lipase (LAL) deficiency. The list of distinguishing descriptors for the …
